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Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
How to support compliance with GAMP 5
KERESZTESI Kálmán
Controsys Irányítástechnikai Kft.
PR
ESEN
TATI
ON
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Agenda
What is GAMP 5 about?
Application Lifecycle Management in automation projects
How to implement GAMP 5 compliant processes in codeBeamer ALM?
Intland's Pharma GAMP 5 Template features
Summary
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
GAMP 5
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Good Automated Manufacturing Practice
GAMP: Name of subcomittee and the Guide
Core principles of GAMP◦ Quality cannot be tested in a batch of product
but must be built into each stage of the manufacturing process
◦ Covers all aspects of production; from the raw materials, facility and equipment to the training and hygiene of staff
◦ Assist pharmaceutical manufacturing companies in managing GxP Regulated systems
GAMP guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner
FOOD & Drug (pharmaceuticals)
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Covarage
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Publications in the GAMP series
Source: https://en.wikipedia.org
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
History of GAMP
1991: UK to satisfy FDA compliance
2000: Part of ISPE: worldwide recognision
2008: Issue GAMP 5
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
GxP-s
Good manufacturing practice (GMP), for food, drug products manufacture & sale
Good agricultural practice (GAP), for farming and ranching
Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals)
Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans
Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation
Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use
Good transportation practice (GTP) deals with the guidelines for the proper domestic and international transportation of medicinal products for human use
Good pharmacovigilance practice (GVP) deals with the safety of produced drugs.
Source: https://en.wikipedia.org
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
GMP: Good manufacturing practice
GMPs are enforced in the United States by the U.S. Food and Drug Administration (FDA), under Title 21 CFR (Code of Federal Regulations)
◦ Practically enforces all companies worldwide exporting to US◦ cGMP: current Good Manufacturing Practices
World Health Organization (WHO) version of GMP
European Union's GMP (EU-GMP)◦ National Regulatory Agencies
UK Medicines Act, The Orange Guide by the MHRA (Medicines and Healthcare products Regulatory Agency)
Inspections by inspectorates◦ Unannounced (FDA – at a reasonable time, allowed in all open business hours)◦ Routine◦ Pre-approval
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Application Lifecycle Management inautomation projects
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
GAMP 5: Risk based Approach
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Life cycle of installed automation sytem
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
3
Project development phase: handling of SW Cat’s
4Future implementationas per end user SOP
5
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Life cycle with development and operations
codeBeamer
codeBeamer
codeBeamer
codeBeamer
codeBeamer
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Implement GAMP 5 compliant processes in codeBeamer ALM
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Integrated GAMP 5 ALM in codeBeamer Current implementation
Project related activities with intensive collaboration need
◦ Fully implemented
Operational phase activities ◦ Implemented
◦ Change management
◦ Observation, deviations
◦ Can be used but no dedicated trackers defined◦ Handover
◦ Patch and Update management
◦ Maintenance, Performance monitoring
◦ Repair
Based on end user SOP
Demand & Concept management
Validation planning
Initial risk and supplier assessment
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Currently implementedin dedicated trackers
Future Future
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Using GAMP compliant process in codeBeamer ALM
Install codeBeamer ◦ Own Windows/Linux server (or Docker environment)◦ Subscribe for SaaS (reluctant in pharma area)
Import Intland’s GAMP 5 Template
Customize template if required (complete redesign possible)◦ User roles◦ Workflows◦ etc.
Make use of customised codeBeamer installation◦ Add users and groups◦ Populate work items and config items◦ Specify, review, test, trace, baseline……
1 hour – 5-10 days based on customisation need
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Intland's Pharma GAMP 5 Template features
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Intland's Pharma GAMP 5 Trackers
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25-27 October 2017
Workflow example
Software design specification workflow:
All workflows are configurable◦ States & Transitions◦ Colors◦ Automatic backgound functions◦ Permissions, etc.
Actual workflow is special to GAMP 5,config tools are generic in codeBeamer
Review & Approval options◦ Workflow based◦ Review HUB based (items groupped)◦ Electronic signature option◦ Multiple reviewer & approver supported
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Collaboration - ResponsibilitiesEnduser
Equipment Supplier
System Integrator
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Tracker relations – key feature in compliance
Based on◦ Built in GAMP rules◦ Collaboration - responsibilities seen on previous slide
Result: the Traceability browser relations
Enable users to ◦ Direct create referring items (use the „+” in Document view)
◦ URS item -> FS item
◦ FS item -> SCS or SDS item◦ etc.
◦ Navigate to related incoming references
Live visualization within codeBeamer◦ Configuration diagram
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
SummaryIntland’s GAMP5 template is a hybrid framework (Waterfall – Agile)
◦ Better response to actual challenges in pharma implementations◦ Full compliance◦ Process control flexibility◦ Complete transparency◦ Offers good ROI (dependent of customer approach – conservative/open)
Current template is project oriented with DevOp features limited ◦ From approved URS to PQ by end user◦ Includes all Functional, System (hw+sw), and Application Design & Verification◦ SCM usable for source file oriented process control systems only (estimated to stay
very limited indeed)◦ Human resources for functional extensions are available
Actual project at Sanofi, in prep. at Gedeon Richter, in use at ABBHU
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
InvitationCoffee break
Round Table on◦ ALM in automation systems◦ codeBeamer ALM◦ GAMP 5 implementation
Miskolc-Lillafüred, Hotel Palota****
25-27 October 2017
Thank you for your attention!
www.controsys.hu